MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; CATHETER, CORONARY, ATHERECTOMY

Model Number	H749394672000
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck in the lesion.The target lesion was located in the left anterior descending artery.A 2.0 mm rotapro was selected for use.During the procedure, the burr catheter was advanced under dynaglide mode near the target lesion without resistance.When dynaglide mode was deactivated to initiate normal rotational operation using the advancer on/off control for lesion treatment, the system immediately exhibited a stall condition.The burr stopped rotating and became stuck, with no forward movement possible despite appropriate manipulation of the advancer.The device was withdrawn and replaced, and the procedure was completed using a different device.There were no patient complications.

• Brand Name: ROTAPRO?
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25162791
• Report Number: 2124215-2026-25863
• Device Sequence Number: 8606272
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)271024(10)37788374
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0037788374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 10/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 72 KG